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Hair RemovalEmeraldNCT03945383

Clinical Investigation of Safety and Effectiveness of Emerald IPLdevice

A study testing Treatment with IPL device in people with Hair Removal, run by Philips Healthcare at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Prospective, multi-center, single-arm, single blinded (Philips hair counter) study in healthy women of skin types I up to and including V. Safety and efficacy of hair removal with the Emerald IPL-device will be investigated for treatment in face of subjects with ST I - IV and for treatment in face, axilla, bikini… Read more about this study

Who is it for?
Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Hair Removal
What is being tested?
Treatment with IPL device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
3 sitesUnited States
Study dates
15 Apr 2019to 14 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Be willing to provide informed consent
  • Are healthy female subjects, in age of 18-65 years
  • Have natural body hair color that is dark blonde, brown or black in the designated treatment areas
  • 3.1. Subjects of ST I-IV - Face group:
  • 3.1.1 Have Fitzpatrick Skin Type I, II, III, or IV
  • 3.1.2 Measure melanin value ≤ 375 in the qualifying treatment areas bilateral on upper lip (face)
Show all 18Show fewer
  • 3.1.3. Have a minimum of 10 hairs in the 1x2cm2 qualifying treatment areas bilateral on upper lip (face), by visual inspection
  • 3.2. Subjects of ST V - All body area group:
  • 3.2.1. Have Fitzpatrick Skin Type V
  • 3.2.2. Measure melanin value ≤ 553 in the qualifying treatment areas bilateral on upper lip (face), axilla, bikini line, and leg
  • 3.2.3. Have a minimum of 10 hairs in the 1x2cm2 qualifying treatment areas bilateral on upper lip (face), by visual inspection
  • 3.2.4.Have a minimum of 24 hairs in each of the 2x4cm2 qualifying treatment areas bilateral on axilla, bikini line, and leg, by visual inspection
  • Be either post-menopausal or surgically sterilized, or using a medically acceptable form of birth control (e.g., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or abstinence, etc.).
  • Be willing to participate in all study visits
  • Be willing to refrain from deliberate exposure to strong sun, products or procedures that would cause the skin to become darker in the designated treatment areas during the treatment phase
  • Be willing to refrain from the use of hair growth inhibitors/accelerators during the course of the study
  • Be willing to refrain from waxing, depilating or epilating of the axilla, bikini line, leg, and face
  • Be willing to refrain from using aspirin or NSAIDs (e.g. acetaminophen, ibuprofen, etc.) within 5 days prior to and 5 days after treatment(s) -

Who cannot join

  • Have natural body hair color that is white, light blond, or red in the designated treatment areas
  • 1.1. Subjects of ST I to IV - Face group:
  • 1.1.1. Have Fitzpatrick Skin Type V or VI
  • 1.1.2. Measure melanin value higher than 375 in the qualifying treatment areas bilateral on upper lip
  • 1.1.3. Have fewer than 2 qualifying treatment areas on bilateral on upper lip (face)
  • 1.2. Subjects of ST V - All body area group:
Show all 40Show fewer
  • 1.2.1. Have Fitzpatrick Skin Type I, II, III, IV, or VI
  • 1.2.2. Measure melanin value higher than 553 in any of the qualifying treatment areas bilateral on the body
  • 1.2.3. Have fewer than 8 qualifying treatment areas bilateral: 2 in face, 2 in axilla, 2 on bikini line, and 2 on legs
  • Have a malignant or pre-malignant pigment in the area to be treated
  • Have scarring or infection of the area to be treated
  • Have a known history of photosensitivity or use of medication known to induce photosensitivity
  • Are currently pregnant or lactating or planning be become pregnant in the period of the study, per subject report
  • Are currently on a daily dose of aspirin or NSAIDs (e.g. acetaminophen, ibuprofen, etc.) or have taken aspirin and/or NSAIDs within 5 days prior to treatment that would reduce or increase the sensation of pain
  • Are not willing to abstain from the use of products or light exposure that would induce tanning in the treatment areas during the IPL treatment period (first 10 months)
  • Have a history of immunosuppressive disease (including HIV infection or AIDS)
  • Are on a anticoagulative medication or thromboembolic condition
  • Have taken any form of isotretinoin (such as Accutane or Roaccutane etc.) in the last six months
  • Have an active implantable device such as a pacemaker, neurostimulator or internal defibrillator
  • Have used waxing or other methods of root hair removal, or photo-epilation in the areas to be treated within 6 months prior to treatment
  • Have been exposed to strong sunlight or an artificial tanning machine in the area to be treated within 4 weeks of enrolment
  • Have a tattoo(s), warts, moles, benign skin lesions, dark pigmented areas, permanent make-up etc. in the areas to be treated.
  • Have eczema, psoriasis, lesions, open wounds or any skin affliction in the areas to be treated
  • Have a history of keloid scar formation
  • Have a history of herpes outbreaks in the areas to be treated
  • Have a history of photosensitive epilepsy
  • Have a condition related to hormonal changes like polycystic ovarian syndrome (PCOS) or taking drugs leading to hormonal changes resulting in excessive hair growth like hirsutism or idiopathic hirsutism
  • Have diabetes, or metabolic disease that affects hair growth
  • Taking immunosuppressive medication(s)
  • Have a disease related to photosensitivity, such as polymorphic light eruption (PMLE), solar urticaria, porphyria etc.
  • Have a history of skin cancer, including past basal cell carcinoma and/or squamous cell carcinoma in the areas to be treated
  • Have a history of any radiation therapy in any of the areas to be treated
  • Have history of radiation therapy in non-treatment areas within 5 years
  • Have a history of chemotherapy
  • Have used hair growth inhibitors and/or accelerators within 6 months preceding enrolment
  • Have had laser or electrolysis treatment for the removal of hair in the areas to be treated within the last year
  • Have natural body hair colors of white, grey, light to mid-blond, or red in the areas to be treated
  • Have bleaching of their body hair in the areas to be treated 6 months prior to study enrolment
  • Have shaved the areas to be treated within 7 days prior to study enrolment
  • Participating in other clinical studies prior to, or concurrently with this study, that could be deemed to interfere with full and complete participation in this study - as determined by the site investigator.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Great Lakes Clinical Trials

    Chicago, Illinois, 60640

  • My Community Research Center

    Miami, Florida, 33155

  • Virginia Clinical Research

    Norfolk, Virginia, 23502

Other trials in United States

About this study

Official title: Clinical Investigation of Safety and Efficacy of the Emerald IPL Device for Hair Reduction for the Extension of Its Intended Use to Face and to Skin Type V Population

Prospective, multi-center, single-arm, single blinded (Philips hair counter) study in healthy women of skin types I up to and including V.

Safety and efficacy of hair removal with the Emerald IPL-device will be investigated for treatment in face of subjects with ST I - IV and for treatment in face, axilla, bikini area, and legs of subjects with ST V.

Read more

In-clinic, the study subjects will undergo twelve IPL-treatments bilaterally at the qualified areas (face and / or axilla, bikini line, and legs) with the Emerald IPL device applied by a device operator.

Hair re-growth in each area will be evaluated separately and across all skin types.

After the 4 bi-weekly treatments, one follow-up visit will be organized two weeks after the 4th treatment. After the completion of the full treatment cycle (12 treatments), subjects will be followed for 1 and 3 months (short-term follow-up) and for 6, 9 and 12 months (long-term follow up).

Read the detailed description

Hair grows in cyclic phases: anagen, catagen and telogen. These phases impact on how the process of light-based hair removal works. The hair grows during the anagen phase, which has the longest duration in the hair growth cycle. Hair growth ends with the transition from anagen into the catagen phase, a short transition phase to prepare for the resting phase, the telogen, which ends with shedding of the hair and the start of the hair growth cycle. During telogen phase, the hair follicle remains inactive. Each hair follicle is independent and goes through the growth cycle at different times. As presented in table 5 [11], the duration of the growth cycle of the upper lip, axilla and bikini line are different from that of the legs. In general, the telogen and anagen phase's durations of the cycle are longest for the legs (i.e., 24 and 16 weeks, respectively) and the shortest for upper lip (i.e. 6 weeks for both phases). Therefore, hair response to the IPL treatment will be evaluated by body area.

The efficacy of permanent hair reduction will be measured following the definition of permanent hair reduction according to the FDA as follows: "Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing after a treatment regime, which may include several sessions. The number of hairs re-growing must be stable over time greater than the duration of the complete growth cycle of hair follicles, which varies from four to twelve months according to body location. Permanent hair reduction does not necessarily imply the elimination of all hairs in the treatment area."

In an attempt to promote permanent hair reduction, the aim is to expose all hairs at least once to an IPL flash and therefore treatment will cover the full duration of a hair growth cycle). The longest relevant full hair growth cycle is on the legs (40 weeks, excluding approximately 2 weeks for the catagen phase). Therefore, a treatment duration of 10 months (approximately 38weeks) has been selected: a full IPL treatment cycle consists of 4 initial treatments, once every 2 weeks, followed by 8 maintenance (monthly) treatments, once every 4 weeks. The hair growth cycle on face (upper lip) is the shortest (12 weeks, 6 weeks in anagen, 6 weeks in telogen phases). The initial treatments in 2 weeks interval are expected to be most beneficial for face treatment.

For this study, there are two cohorts for enrollment:

  1. Subjects with Skin Type I-IV for treatment of Face only. (N=53)
  2. Subjects with Skin Type V for treatment of all body areas: Face, Axilla, Bikini line and leg. (N=19)

The visits are as follows:

Screening Visit: The volunteers are screened to identify subjects who meet all of the inclusion and none of the exclusion criteria. Device settings are selected based on skin tone and comfort evaluation..

Visits 1-4 (TX1-TX4): Four treatments and the collection of safety and efficacy data are scheduled to occur every 2 weeks/ 14 days; Visits 5 (Initial Treatment 2wk Follow-up): Safety and efficacy data are collected 2 weeks/ 14 days after 4th treatment to demonstrate hair removal performance 8 weeks after baseline.

Conditions
Hair Removal
Being tested
Treatment with IPL device

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment with IPL deviceDevice

    Treatment with IPL device

Study groups in NCT03945383
Study groupRoleWhat they receive
Treatment with IPL deviceExperimentalThe Emerald IPL device is applied by the Investigator or designee to the right and left side of the body. Treatment areas are 2x4 cm2 for the leg and bikini line areas. The entire axilla and face (upper lip) area will be treated due to the small area involved.
Receives: Device: Treatment with IPL device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of subjects with at least 30% hair reduction relative to baseline at 8 and 10 weeks after baseline and at 1 and 3 months after last treatment

    Efficacy of the device will be measured by evaluating the proportion of subjects with >= 30% hair reduction on the face, axilae, bikini area and legs following the intensive treatment phase at 8 and 10 weeks as well as during short term follow up of 1 month and 3 months after the last treatment.

    Measured: approximately 13 months

Secondary outcomes (4)

  1. Safety will be measured by proportion of treatment-emerged, anticipated adverse events, non-anticipated adverse events, serious adverse events and other related reasons for discontinuation.

    The primary safety endpoints include the treatment-emerged, anticipated adverse events, non-anticipated adverse events, serious adverse events and reasons for discontinuation during the treatment of the face, axilae, bikini area and legs with the device as well as during the follow-up period.

    Measured: Approximately 22 months

  2. Assessment of the subjective satisfaction with the treatment results of the Emerald IPL device for removal of unwanted hair on face, axillae, bikini area, and legs: 5-point Likert satisfaction scale

    Percent of top-two category answers of 5-point Likert satisfaction scale in assessment of subjective satisfaction with the treatment results in all body areas.

    Measured: Approximately 22 months

  3. Assessment of the acceptance of the Emerald IPL devices for removal of unwanted hair in each body area: Percent of top-two category answers in assessment of acceptance

    Percent of top-two category answers in assessment of acceptance of hair reduction, skin smoothness, and comfort after treatment with Philips investigational IPL devices in all body areas.

    Measured: Approximately 22 months

  4. Proportion of subjects with at least 30% hair reduction relative to baseline at 6, 9 and 12 months post-final treatment per body area.

    Efficacy of the device will be measured by evaluating the proportion of subjects with >= 30% hair reduction on the face, axilae, bikini area and legs during the long term follow up of 1 month and 3 months after the last treatment.

    Measured: Approximately 22 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2019
  2. Study start15 Apr 2019
  3. Primary completion14 Jan 2022
  4. Study completion14 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All enrolled subjects will be treated with the investigational device
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03945383
Sponsor's protocol ID
PC-BEA-Emerald STV&Face-10560
Acronym
Emerald
Status last verified
Oct 2022
First submitted
29 Apr 2019
Last updated
19 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Altshuler GB, Anderson RR, Manstein D, Zenzie HH, Smirnov MZ. Extended theory of selective photothermolysis. Lasers Surg Med. 2001;29(5):416-32. doi: 10.1002/lsm.1136.

    PubMed 11891730

  • Ravnbak MH. Objective determination of Fitzpatrick skin type. Dan Med Bull. 2010 Aug;57(8):B4153.

    PubMed 20682135

  • Shamsuddin K et. al, The reliability of Fitzpatrick Skin Type Chart Comparing to Mexameter (Mx 18) in measuring skin color among first trimester, Malaysian Journal of Public Health Medicine 2016, Vol. 16 (3): 59-65

  • Gold MH, Bell MW, Foster TD, Street S. Long-term epilation using the EpiLight broad band, intense pulsed light hair removal system. Dermatol Surg. 1997 Oct;23(10):909-13. doi: 10.1111/j.1524-4725.1997.tb00746.x.

    PubMed 9357500

  • Gold MH, Bell MW, Foster TD, Street S. One-year follow-up using an intense pulsed light source for long-term hair removal. J Cutan Laser Ther. 1999 Sep;1(3):167-71. doi: 10.1080/14628839950516823.

    PubMed 11360413

  • Dierickx CC. Hair removal by lasers and intense pulsed light sources. Dermatol Clin. 2002 Jan;20(1):135-46. doi: 10.1016/s0733-8635(03)00052-4.

    PubMed 11859588

  • Thaysen-Petersen D, Bjerring P, Dierickx C, Nash JF, Town G, Haedersdal M. A systematic review of light-based home-use devices for hair removal and considerations on human safety. J Eur Acad Dermatol Venereol. 2012 May;26(5):545-53. doi: 10.1111/j.1468-3083.2011.04353.x. Epub 2011 Nov 30.

    PubMed 22126235

  • Town G, Ash C, Dierickx C, Fritz K, Bjerring P, Haedersdal M. Guidelines on the safety of light-based home-use hair removal devices from the European Society for Laser Dermatology. J Eur Acad Dermatol Venereol. 2012 Jul;26(7):799-811. doi: 10.1111/j.1468-3083.2011.04406.x. Epub 2012 Jan 3.

    PubMed 22211702

  • Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available.

    PubMed 3377516

Questions about this trial

What is this clinical trial studying?

A study testing Treatment with IPL device in people with Hair Removal, run by Philips Healthcare at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects with at least 30% hair reduction relative to baseline at 8 and 10 weeks after baseline and at 1 and 3 months after last treatment (time frame: approximately 13 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03945383, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.

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